Protocol summary

Summary
Paclitaxel is widespreadly used in chemotherapy diets due to its antitumor activity, which causes severe and even lethal toxicity and also severe allergic reactions. Abraxan is an albumin-bound formulation derived from Paclitaxel which lacks paclitaxel-related toxicities. Recently, a formulation similar to Abraxan, nemed Paclinab, have been produced which in vitro studies indicate its acceptable function. Therefore, this study is aimed to evaluate Paclinab efficiency and its comparison with Abraxan in pancreatic cancer patients. This study will perform in two groups, on twenty pancreatic cancer patients with a randomized crossover diet containing paclitaxel for comparison of Paclinab and Abraxan formulations. In the first cycle, one group will receive a dosage of Paclinab and another one will receive a dosage of Abraxan (125 mg/m2 of body surface area during 30 min infusion), under medical care. In next cycle (3-week cycles) the group which received Abraxan, will receive Paclinab and the other group will receive the drug with the same dosage, vice versa. assessment of blood samples will be done for comparison of pharmacokinetic parameters of both formulations at different times, before the infusion initiation, 15 min after the infusion initiation, 2-5 min before the infusion termination, and also 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h after infusion termination. Measurement of Paclitaxel is performed in all samples using a high fluid pressure chromatography analysis method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041118745N4
Registration date: 2016-06-10, 1395/03/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nano Daru Pajuhan Pardis Co
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pharmacokinetic evaluation of Paclynap formulation in comparison with Abraxan in pancreatic cancer patients
Public title
Evaluation of blood levels of Paclynap produced drug in Iran in comparison with Abraxan in pancreatic cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: with written consent; patients with Local Advanced Pancreatic Cancer. exclusion criteria: patients with hepatic and renal disorders; patients with acute and chronic heart disease; patients with pulmonary and cerebral metastasis; patient with decreased albumin levels of two times of normal; patients with enhanced blood bilirubin of 3 times over.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University Vice Chancellor for Research and Technology, Quds Street intersection with Keshavarz Bulvar, Tehran
City
Tehran
Postal code
Approval date
2016-04-06, 1395/01/18
Ethics committee reference number
IR.TUMS.REC.1395.2323

Health conditions studied

1

Description of health condition studied
Pancreas cancer
ICD-10 code
C25
ICD-10 code description
Malignant neoplasm of pancreas

Primary outcomes

1

Description
Paclytaxel serum level
Timepoint
30 min, one, two, four, six, eight, twelve, twenty four, forty eight hours after injection
Method of measurement
High fluid pressure chromatography

Secondary outcomes

1

Description
decrease of tumor
Timepoint
Two months after injection
Method of measurement
Imaging using MRI

Intervention groups

1

Description
The randomized crossover study will be performed on two groups. The first group which will initially receive abraxan: This group will initially receive abraxan (125 mg / m2 of body surface area at the first cycle at days 1, 8 and 15). Then in the next cycle, after one week relaxation, the patients will receive paclinab (125 mg / m2 of body surface area at days 28, 35 and 42).
Category
Treatment - Drugs

2

Description
The second group which will initially receive paclynap: This group will initially receive paclynap (125 mg / m2 of body surface area at the first cycle at days 1, 8 and 15). Then in the next cycle after one week relaxation, the patients will receive abraxan (125 mg / m2 of body surface area at days 28, 35 and 42).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Cancer Institute
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
Cancer Research Center, Cancer Institute, Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nano Daru Pajuhan Pardis Co
Full name of responsible person
Navid Goodarzi
Street address
unit 2, No. 33, Bagher Street East, Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Daru Pajuhan Pardis Co
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
PhD
Other areas of specialty/work
Street address
Cancer Research Center, Cancer Institute, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2798
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
PhD
Other areas of specialty/work
Street address
Cancer Research Center, Cancer Institute, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2798
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
pccrg@org

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
PhD
Other areas of specialty/work
Street address
Cancer Research Center, Cancer Institute, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2798
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
pccrg@org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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